Transportable apparatus for treating Meniere&#39;s disease

ABSTRACT

A transportable apparatus for treating Ménière&#39;s disease comprises electronically controlled pressure variation unit housed in an inner casing which is partially enclosed by an outer casing provided with an opening covered by a removable cover. A storage compartment is disposed between the casings to receive a flexible tube provided with an ear plug. The flexible tube is connected to the pressure variation unit. The storage compartment surrounds a first portion of the inner casing in which the flexible tube can be disposed in a coiled manner.

FIELD OF THE INVENTION

The present invention relates to a transportable apparatus for treatingMénière's disease and similar conditions which affect the pressurebalance between the various compartments of the internal ear.

BACKGROUND OF THE INVENTION

Ménière's disease can be treated by affecting the pressure in theinternal ear, in particular the endolymphatic system. A number ofapparatus for carrying out this treatment are known in the art. Theycomprise a pressure generating/control unit to which a flexible tubeprovided with an ear plug is coupled for conducting pressure pulses to apatient's external ear.

WO 83/02556 discloses an apparatus for influencing the hydrodynamicsystem of the inner of an ear comprising a displaceable diaphragmforming the wall of an air pressure generating chamber, the diaphragmbeing reciprocally displaceable by means of a crank coupling in adirection away from the chamber against the force of a spring coil.

WO 93/08775 discloses an air pressure generator for the treatment ofMénière's disease by pressure pulses generated by a flexible membraneforming a wall in a pressure generating chamber, the membrane beingdisplaced by actuation means rigidly coupled to the shaft of anelectrical motor.

WO 97/23178 discloses a device for affecting the hydrodynamic system ofthe inner ear comprising first means for generating a static pressurelevel and second means for causing a variation of that level inaccordance with a predetermined program controlled by a control unit.Each of the first and second means comprise a flexible membrane (100,200). Also in this known apparatus one half of the reciprocatingmovement of the diaphragm, the one in which the diaphragm moves towardsthe pressure generating chamber, is caused by spring means.

The design of these apparatus is silent about the patient's need forambulant treatment. To allow the patient to live a life as normal aspossible and, in particular, to travel, it should be possible toadminister the treatment wherever the patient happens to be. Since suchadministration implies that that it would have to be carried out in theabsence of competent health care personnel self-administration should bepossible. A transportable apparatus for personal use should also be of adesign protecting its delicate parts and the flexible tube/earplug fromdamage and dirt, and its maneuver organs from inadvertent manipulation.

OBJECTS OF THE INVENTION

It is an object of the present invention to provide an apparatus fortreatment of Ménière's disease and similar conditions by affecting thepressure in the internal ear which is easy to transport by the patientto be used whenever there is a need for treatment, and which takes intoaccount and solves the aforementioned design problems.

It is another object of the invention to provide such an apparatuswhich, in addition, can be operated by the patient without assistance byothers.

SUMMARY OF THE INVENTION

According to the present invention is provided an apparatus of theaforementioned kind, comprising electronically controlled pressurevariation means housed in an inner casing, the inner casing beingpartially enclosed by an outer casing provided with an opening coveredby a removable cover, a storage compartment disposed between thecasings, a flexible tube connected to said pressure variation means atits one end and being provided with an ear plug at its other end, theflexible tube being disposable in the storage compartment and removabletherefrom with its free end carrying the ear plug for administration ofpressure pulses to the external ear of a patient. This solves animportant problem since the flexible tube has to be about half a meterlong at minimum to allow its ear plug to be fixed to the patient'sexternal ear. If not stored and protected properly it would have atendency to intertwine and fasten with the ear plug in other gear. Thistube length is required for convenient self treatment during which thepatient sits at a table while the apparatus rests on the table beforehim or her.

According to a preferred aspect of the invention the storage compartmentsurrounds a first portion of the inner casing; preferably the flexibletube is disposed in a coiled manner around that portion. This designprovides additional shielding for the most sensitive elements of theapparatus while providing for easy deposition of the tube after atreatment session.

According to a second preferred aspect of the invention the firstportion 1 a of the inner casing is removable from a second portion 16 ofthe inner casing. Preferably the second portion 16 of the inner casingand the outer casing are made from one piece of material. By removingthe first portion of the inner casing the electronics and the mechanicalparts of the apparatus become accessible for adjustment or repair by atechnician without having to disassemble the apparatus. Electronic andmechanical elements of a delicate nature can be disposed in a way thatmakes them face the first portion. Thereby they are optimally protectedby being mounted in the innermost part of the apparatus while remainingeasily accessible from outside for repair and testing.

Also preferred is to make the flexible tube pass through an opening inthe first portion of the inner casing.

According to a third preferred aspect of the invention the first portionof the inner casing is provided with a panel for control of theapparatus by the patient. Thereby an inadvertent start or othermanipulation of the apparatus' maneuver organs is prevented.

To protect the patient from damage the apparatus of the invention isconfined to working pressures not exceeding 30 cm of water column. Thisis achieved by providing the apparatus with a pressure sensor and toprogram the microprocessor to open a safety valve once the maximumtolerable pressure is reached.

Advantageously the apparatus of the invention comprises a rechargeablebattery in a battery compartment and an electrical connector forconnection to a battery eliminator. The battery compartment isadvantageously disposed in a way to make it accessible from the rear(bottom) side of the apparatus, that is, the side on which the apparatusstands when in use.

Further preferred features of the present invention are disclosed in theappended claims and a preferred embodiment illustrated in a roughdrawing, in which is shown in

FIG. 1 the apparatus of the invention, in a side view from above, withthe casing cover in an open position, and with the flexible tube in astored (coiled) condition;

FIG. 2 the apparatus of FIG. 1 and in the same view, with the flexibletube provided with an earplug in an uncoiled position ready forconnection to the external ear of a patient;

FIG. 3 the apparatus of FIG. 1, in a vertical section along its largestdiameter, without the flexible tube and with the cover in a closedposition.

The apparatus of the invention shown in FIGS. 1–3 comprises an innercasing 1 of having about the form of an ellipsoid delimited by two basesperpendicular to its the axis of symmetry and thus parallel to eachother. One end portion or the inner casing 1 is surrounded by the wallof an outer casing 2 which is also ellipsoid in form and shares the axisof symmetry casing 1. The ellipsoid wall of the outer casing 2 is spacedapart from the inner casing 1 to which it is joined by a bottom flange 3forming the peripheral part of what would be its one basis. Thereby anannular space or groove 6 of elliptic form is formed. Any other suitableform of the apparatus, such as a circular form, would be equallypossible.

The other (topside) basis of outer casing 2 is lacking. Instead theouter casing 2 is provided with an elliptical flat cover 4 fastened by ahinge 14 to let it be opened and closed. For most of its circumference,except for a portion in the proximity of the hinge 14, the cover 4 isprovided with a rim 15 which overlaps a the outer casing 2 wall when thecover 4 is in a closed position in which it can be releaseably securedto the outer casing 2 (not shown). A simple snap lock (not shown) holdsthe cover 4 in the closed position; it is moulded into appropriatesuperimposed (when closed) portions of the inside of rim 15 and theoutside of the outer casing 2 wail.

The inner casing 1 contains a pressure generating unit 7 for generatingthe variations in air pressure to be adduced to the external ear of apatient and, from there, to the patient's internal ear through a tinytube implanted in the tympanic membrane. The pressure generating unit 7may comprise a diaphragm pump operated by electrically driven actuatingmeans, such as the assembly disclosed in WO 97/23178. It is onlyindicated in a general way in FIG. 3. The pressurized air outlet of thepressure generating unit 7 has the form of a nipple 10 suitable forattaching one end of a flexible plastic tube 11 the other end of whichcaries an earplug 13 to be inserted into one of the the patient'sexternal ears.

The flexible tube 11 extends through a circular opening 8 into theelliptical circumferential groove 6 in which it can be wound up when theapparatus of the invention is not being used. This condition is shown inFIG. 1. The free end 12 of the flexible tube 11 normally carries anearplug 13 which has been omitted in FIG. 1 for reasons of clarity.Though being substantially thicker than the flexible tube 11 the earplug13 can also be stored in the elliptical groove 6 by a design making thegroove to widen at a portion 9 of the inner casing 1 wall deviating inthe direction of the axis of symmetry of the ellipsoid; the opening 8 isarranged in this wall portion 9.

FIG. 2 shows the apparatus of the invention ready for use. The flexibletube 11 is unwound and disposed for most of its length outside of theapparatus of the invention.

The apparatus in FIGS. 1–3 is intended to be put on a horizontal supportwith its flat underside, the basis pertaining to the portion of theinner casing 1 extending exteriorly of the outer casing 2.

In addition the inner casing 1 houses an only schematically illustratedelectronic control unit 17 including a microprocessor for controllingthe generation of the pressure pulses in the pressure generating unit 7.Energy for several treatments can be stored in rechargeable batteries 23disposed in a separate battery compartment 24 accessible from theunderside of the apparatus by removing the compartment lock 25.Miniature contacts accessible from outside for recharging the batteries23 through a battery eliminator are not shown in the Figures; the sameis true for other electrically operated equipment known in the art, suchas a valve for equalizing air pressure in the pressure generating unit 7and a safety valve.

The top wall 5 of the inner casing 1 is provided with a panel 18 foroperation of the apparatus by the patient. The panel 18 comprises anon/off touch switch 19 and four diode lights 20 indicating, to thepatient: whether the apparatus is pumping or not; the completion of atreatment session; that the manual should be consulted; that there is aleakage.

The portion 1 a of the inner casing 1 enclosed by the outer casing 2 ismounted by screws 22 to the combination of the not-enclosed portion 16of the inner casing and the outer casing 2 which is made in a singlepiece of a hard polymer material; the same material is used for saidmounted portion of the inner casing 1 and the outer casing cover 4. Thisdesign provides convenient access to the various parts housed in theinner casing 1.

The apparatus of the invention can be made to a size and a weight whichmake it convenient to carry. The casings can be manufactured byinjection moulding from a variety of polymer materials. A prototype ofweighing about 550 g has been tested in patients with good results.

1. A transportable apparatus for treating Ménière's disease and similarconditions affecting the pressure balance between the variouscompartments of the internal ear, comprising a mechanical,electronically controlled pulse generator housed in an inner casing andoperable for generating pressure pulses having pulse characteristicsadapted for treating Ménière's disease and similar conditions affectingthe pressure balance between the various compartments of the internalear, the inner casing being partially enclosed by an outer casing, astorage compartment disposed between the casings, a flexible tubeconnected to said mechanical pulse generator at its one end and beingprovided with an ear plug at its other end, the flexible tube beingdisposable in the storage compartment and removable therefrom with itsfree end carrying the ear plug for administration of said pressurepulses to the external ear of a patient, said storage compartmentsurrounding a first portion of the inner casing around which theflexible tube is disposable in a coiled manner.
 2. The apparatus ofclaim 1, wherein said first portion is removable from a second portionof the inner casing.
 3. The apparatus of claim 2, wherein said secondportion of the inner casing and the outer casing are made from one pieceof material.
 4. The apparatus of claim 1, wherein said first portion ofthe inner casing is provided with a panel for control of the apparatusby the patient.
 5. The apparatus of claim 1, wherein the flexible tubepasses through an opening in said first portion of the inner casing. 6.The apparatus of claim 1, wherein the pressure pulses do not exceed 30cm of water column.
 7. The apparatus of claim 1, comprising arechargeable battery in a battery compartment and an electricalconnector for connection to a battery eliminator.
 8. The apparatus ofclaim 1, wherein said removable cover is hinged to said outer casing. 9.The apparatus of claim 1, wherein said first portion of said firstcasing is enclosed within a space defined by said outer casing, whilesaid second portion of said first casing extends beyond said spacedefined by said outer casing.
 10. The apparatus of claim 1, saidmechanical pulse generator comprising a first device for generating astatic pressure level and a second device for causing a variation ofthat static pressure level in accordance with a predetermined program.